FDA.reportPublic FDA data

Update - 85424-014-01

Manufacturer
RoyceDerm LLC
Effective date
2026-08-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-18 02:02:30

Label at a glance#

ProductRoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 3%

OTC - PURPOSE SECTION

Anti-Seborrheic Dermatitis, Anti-Psoriasis

DOSAGE & ADMINISTRATION SECTION

  • Controls the symptom of seborrheic dermatitis & psoriasis
  • Helps prevent recurrence of skin & scalp itching, irritation, redness, flaking, scaling, associated with psoriasis & seborrheic dematitis

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

  • Ask a doctor before use you havea condition that covers a large area of the body.
  • When usingthis product avoid contact with eyes. If contact occurs, rinse theeyes thoroughly with water.
  • Stop and ask a doctor if conditionworsens or does not improve after regular use of this productas directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, getmedical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Adults and children 12 years and older: Apply to affected areasone to four times daily or as directed by a doctor.

OTHER SAFETY INFORMATION

Store at room temperature & out of direct sunlight

INACTIVE INGREDIENT SECTION

Water (Aqua), Artemisia Vulgaris Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia ScopariaFruit Extract, Dictamnus Dasycarpus Root Bark Extract, Smilax Glabra Root Extract, Phellodendron Amurense Bark Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-01485424-014-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ARTEMISIA VULGARIS OIL72Q967Y48VIACT
BASSIA SCOPARIA FRUIT04W97Z676YIACT
DICTAMNUS DASYCARPUS ROOT BARKLA97176ILSIACT
SMILAX GLABRA WHOLEH51N91QNEBIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
CNIDIUM MONNIERI FRUIT OILJK0MS9P8YLIACT
PHELLODENDRON AMURENSE BARKPBG27B754GIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-28full-release2026-06-01 01:46:06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC496e178b-e29b-071e-e063-6394a90aa0182026-08-13WarningsExact identifier
ndc (package): 85424-014-01
ndc (product): 85424-014
ndc11 (package): 85424001401
spl id: 58f4e362-f8a4-4be8-e063-6394a90a84cc
spl set id: 496e178b-e29b-071e-e063-6394a90aa018

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.